Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04649034
Status:
RECRUITING
Last Update Posted:
2023-09-22
First Post:
2020-11-24
Brief Title:
Intraventricular Stasis In Cardiovascular Disease
Sponsor:
Hospital General Universitario Gregorio Marañon
Organization:
Hospital General Universitario Gregorio Marañon
Study Overview
Official Title:
Personalizing The Risk Of Stroke And Silent Brain Infarct In Cardiovascular Disease
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISBIFLOW
Brief Summary:
This study is designed to quantify the ventricular stasis in patients with different forms of cardiomyopathy and at risk of stroke ischemic non-ischemic dilated cardiomyopathy and hypertrophic cardiomyopathy by post-processing of 2D color Doppler echocardiography and phase contrast-magnetic resonance images in order to establish the relationship between quantitative variables of intraventricular stasis and the prevalence of silent embolic events andor intraventricular mural thrombosis
Detailed Description:
Cardioembolic stroke is a major source of mortality and disability worldwide and blood stasis inside the heart is the main risk factor for developing intracardiac thrombosis We have recently developed and patented a quantitative image-based method to map blood stasis within the cardiac chambers The method is suitable for any medical imaging modality that provides time-resolved flow maps inside the heart magnetic resonance echocardiography or computational-fluid-dynamic processing from anatomical CT images The objective of the present project is to validate this certified technology in a multicentric cross-sectional clinical trial of 258 patients with different forms of cardiomyopathy with high-risk of stroke
We will include patients with ischemic non-ischemic dilated cardiomyopathy and hypertrophic cardiomyopathy in sinus rhythm and an echocardiogram cardiac and cerebral MRI will be performed Our objective is to quantify the ventricular stasis by post-processing of 2D color Doppler echocardiography and phase contrast-magnetic resonance images in order to establish the relationship between quantifiable intraventricular stasis variables and the prevalence of silent brain infarctions SBIs and intracavitary thrombosis determined by magnetic resonance MRI
We will include patients with ischemic non-ischemic dilated cardiomyopathy and hypertrophic cardiomyopathy in sinus rhythm and an echocardiogram cardiac and cerebral MRI will be performed Our objective is to quantify the ventricular stasis by post-processing of 2D color Doppler echocardiography and phase contrast-magnetic resonance images in order to establish the relationship between quantifiable intraventricular stasis variables and the prevalence of silent brain infarctions SBIs and intracavitary thrombosis determined by magnetic resonance MRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None